Z-0727-2021Class II

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Name: Z-0727-2021 ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Creator: Philips Home Healthcare Solution
Published: 2020-12-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-12-08 / Terminated

FDA source

PHILIPS HOME HEALTHCARE SOLUTION began a recall of ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system on 2020-12-08. FDA classified it as Class II and gives the reason as "After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0727-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-08
Posted: 2021-01-28
Terminated: 2024-06-21
Recalling firm: Philips North America LLC
Product: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
FDA root cause: Radiation Control for Health and Safety Act
Quantity in commerce: 91
Distribution: Nationwide
Product codes and lots: Pending

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2021	Class II	Terminated	FDA Mandated	2021-02-03	2020-12-31

Product code OWB

K173433Class IIProxiDiagnost N90Philips Medical Systems Dmc GmbH / cleared 2018-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)